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Trial record 29 of 231 for:    CALCITONIN SALMON

Calcitonin Gene-related Peptide Levels in Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071096
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : February 17, 2012
Last Update Posted : February 12, 2013
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Cady, Roger, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Migraine
Interventions Drug: OnabotulinumtoxinA
Drug: Saline
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211). Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
Period Title: First Intervention (90 Days)
Started 10 10
Completed 9 10
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Period Title: Washout Period (30 Days)
Started 9 10
Completed 9 10
Not Completed 0 0
Period Title: Second Intervention (90 Days)
Started 9 10
Completed 9 10
Not Completed 0 0
Arm/Group Title Enrolled Participants
Hide Arm/Group Description Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
48.45  (12.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
15
  75.0%
Male
5
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.
Hide Description Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.
Time Frame Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: days
Baseline vs. Month 1 -7.61  (8.01) -6.67  (6.28)
Baseline vs. Month 2 -9.72  (5.96) -5.22  (4.44)
Baseline vs. Month 3 -10.06  (5.92) -5.22  (5.14)
Baseline vs. Month 4 -9.50  (8.34) -6.89  (7.08)
Baseline vs. Month 5 -8.94  (8.15) -6.33  (4.12)
Baseline vs. Month 6 -9.50  (7.93) -9.22  (5.45)
Baseline vs. Month 7 -6.50  (7.53) -4.56  (6.89)
2.Primary Outcome
Title Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).
Hide Description Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.
Time Frame Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:
OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: days
Baseline vs. Mo 1 -7.61  (8.01) -6.67  (6.28)
Mo 1 vs. Mo 2 -2.11  (7.20) 1.44  (7.78)
Mo 2 vs. Mo 3 -0.33  (3.97) 0.00  (1.94)
Mo 3 vs. Mo 4 0.56  (3.91) -1.67  (5.66)
Mo 4 vs. Mo 5 0.56  (3.21) 0.56  (4.61)
Mo 5 vs. Mo 6 -0.56  (3.84) -2.89  (5.42)
Mo 6 vs. M 7 3.00  (3.84) 4.67  (5.63)
3.Secondary Outcome
Title Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)
Hide Description CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month.
Time Frame Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OnabotulinumtoxinA Saline
Hide Arm/Group Description:
This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7).
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
Overall Number of Participants Analyzed 19 19
Mean (Standard Error)
Unit of Measure: pmol/mg total protein
Treatment Month 1 39.64  (7.5) 40.79  (9.73)
Treatment Month 2 28.37  (7.07) 39.14  (9.74)
Treatment Month 3 26.14  (3.93) 50.63  (15.04)
4.Secondary Outcome
Title Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline
Hide Description Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication.
Time Frame For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OnabotulinumtoxinA Responders OnabotulinumtoxinA Non-Responders Saline
Hide Arm/Group Description:
This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with >30% reduction in number of headache days per month when compared to Baseline
This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with <30% reduction in number of headache days per month when compared to Baseline
This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
Overall Number of Participants Analyzed 10 9 19
Mean (Standard Deviation)
Unit of Measure: pmol/mg total protein
Treatment Month 1 - Baseline 52.36  (56.31) 29.36  (32.81) 70.46  (98.26)
Treatment Month 1 - Attack 27.94  (21.85) 22.36  (20.38) 36.23  (33.16)
Treatment Month 1 - 2 Hours Post 61.55  (44.82) 23.66  (12.11) 39.76  (54.51)
Treatment Month 2 - Baseline 59.89  (49.27) 28.66  (20.59) 44.12  (49.70)
Treatment Month 2 - Attack 60.14  (51.18) 32.65  (33.80) 33.05  (30.96)
Treatment Month 2 - 2 Hours Post 39.13  (60.98) 22.35  (19.94) 33.93  (35.91)
Treatment Month 3 - Baseline 51.33  (77.44) 32.61  (40.13) 58.74  (53.86)
Treatment Month 3 - Attack 73.18  (58.88) 30.17  (38.63) 46.16  (40.29)
Treatment Month 3 - 2 Hours Post 54.04  (34.77) 19.11  (13.24) 49.39  (43.81)
5.Secondary Outcome
Title Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders
Hide Description Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, & 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES)
Time Frame For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed is low due to some unusable samples and missing samples making comparison between months impossible. 5 Responders and 5 Non-Responders provided enough samples at all time points for comparisons.
Arm/Group Title Month 1 vs. Saline Responders Month 1 vs. Saline Non-Responders Month 3 vs. Saline Responders Month 3 vs. Saline Non-Responders Month 1 vs. Month 3 Responders Month 1 vs. Month 3 Non-Responders
Hide Arm/Group Description:
Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with >30% reduction in number of headache days per month from baseline.
Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with <30% reduction in number of headache days per month from baseline.
Overall Number of Participants Analyzed 5 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: Florescent Units (FU)
C5/C5a 1.38  (0.23) 1.01  (0.90) 1.39  (0.80) 1.61  (0.54) 1.03  (0.57) 3.26  (3.35)
CD40 Ligand 1.09  (0.25) 1.26  (0.99) 0.98  (0.37) 1.31  (0.63) 0.91  (0.27) 1.22  (0.40)
G-CSF 0.92  (0.45) 0.93  (0.55) 0.85  (0.24) 0.99  (0.58) 1.07  (0.74) 1.34  (0.76)
GROa 1.34  (1.56) 3.18  (2.20) 1.40  (1.33) 1.81  (1.32) 1.05  (0.96) 0.73  (0.55)
sICAM-1 2.60  (2.32) 0.61  (0.54) 5.99  (6.13) 2.00  (1.98) 3.99  (3.22) 1.51  (0.15)
IFN-y 1.29  (0.34) 0.80  (0.69) 1.29  (0.82) 1.92  (2.95) 0.91  (0.34) 1.63  (0.94)
IL-1alpha 2.30  (1.86) 2.88  (4.29) 1.50  (0.92) 2.14  (3.04) 0.86  (0.60) 0.81  (0.32)
IL-1beta 1.63  (0.80) 1.12  (1.09) 1.38  (1.15) 0.51  (0.23) 1.15  (0.12) 1.03  (0.43)
IL-1ra 1.13  (0.56) 2.02  (2.66) 0.96  (0.39) 1.90  (1.58) 0.88  (0.12) 1.30  (0.43)
IL-8 1.61  (0.83) 1.70  (2.03) 2.71  (2.29) 1.22  (1.24) 4.38  (6.98) 2.28 [1]   (NA)
IL-16 0.91  (0.63) 2.07  (1.63) 0.75  (0.48) 1.97  (1.64) 0.98  (0.66) 1.10  (0.48)
IL-17E 0.86  (0.50) 1.02  (0.91) 1.59  (1.79) 0.42  (0.13) 1.28  (0.85) 1.45  (0.04)
IL-23 2.45  (1.85) 1.80  (1.55) 1.06  (0.12) 1.69  (1.54) 0.93  (0.01) 2.61  (3.34)
IP-10 1.32  (1.05) 0.95  (0.17) 0.86  (0.52) 2.76  (2.23) 1.55  (1.50) 3.11  (2.69)
I-TAC 1.40  (0.78) 0.28  (0.12) 1.01  (0.89) 0.94  (0.26) 0.67  (0.27) 3.65  (1.33)
MIF 3.71  (6.25) 9.55  (19.47) 2.71  (4.50) 8.66  (16.79) 0.80  (0.32) 1.24  (0.27)
Serpin E1 0.98  (0.17) 0.70  (0.53) 0.70  (0.33) 0.90  (0.82) 0.76  (0.39) 3.16  (3.25)
RANTES 0.95  (0.41) 0.77  (0.28) 0.93  (0.41) 0.91  (0.27) 1.14  (0.21) 1.24  (0.26)
[1]
Only one value available (2.28) so there is no standard deviation between reported values.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline OnabotulinumtoxinA
Hide Arm/Group Description Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1) Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
All-Cause Mortality
Saline OnabotulinumtoxinA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Saline OnabotulinumtoxinA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Saline OnabotulinumtoxinA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/20 (55.00%)      15/20 (75.00%)    
Blood and lymphatic system disorders     
Contusion of extremity   0/20 (0.00%)  0 1/20 (5.00%)  1
Elevated Cholesterol   0/20 (0.00%)  0 1/20 (5.00%)  1
Enlarged Lymph Node   0/20 (0.00%)  0 1/20 (5.00%)  1
Cardiac disorders     
Coronary Artery Disease   0/20 (0.00%)  0 1/20 (5.00%)  1
Heart Arrhythmia   1/20 (5.00%)  1 0/20 (0.00%)  0
Ear and labyrinth disorders     
Inner Ear Fluid Imbalance   0/20 (0.00%)  0 1/20 (5.00%)  1
Otitis   1/20 (5.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
Diverticulitis   1/20 (5.00%)  1 0/20 (0.00%)  0
Gastroenteritis   1/20 (5.00%)  1 0/20 (0.00%)  0
Influenza   0/20 (0.00%)  0 1/20 (5.00%)  1
Parotid Glad Infection   0/20 (0.00%)  0 1/20 (5.00%)  1
Salivary Gland Infection   0/20 (0.00%)  0 1/20 (5.00%)  1
Salivary Gland Obstruction   0/20 (0.00%)  0 1/20 (5.00%)  1
Vomiting   0/20 (0.00%)  0 1/20 (5.00%)  1
General disorders     
Chest Pain   1/20 (5.00%)  1 0/20 (0.00%)  0
Chills   1/20 (5.00%)  1 0/20 (0.00%)  0
Head Pain   0/20 (0.00%)  0 1/20 (5.00%)  1
Head Tenderness   0/20 (0.00%)  0 1/20 (5.00%)  2
Hoarseness   1/20 (5.00%)  1 0/20 (0.00%)  0
Pyrexia   1/20 (5.00%)  1 0/20 (0.00%)  0
Scalp Pain   0/20 (0.00%)  0 1/20 (5.00%)  1
Stress   0/20 (0.00%)  0 1/20 (5.00%)  1
Vertigo   1/20 (5.00%)  1 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Eyebrow Ptosis   0/20 (0.00%)  0 1/20 (5.00%)  1
Neck Pain   0/20 (0.00%)  0 5/20 (25.00%)  5
Shoulder Pain   1/20 (5.00%)  1 0/20 (0.00%)  0
Nervous system disorders     
Fibromyalgia Pain   0/20 (0.00%)  0 1/20 (5.00%)  1
Headache   1/20 (5.00%)  1 1/20 (5.00%)  1
Paresthesia as Injection Site   0/20 (0.00%)  0 1/20 (5.00%)  1
Somnolence   0/20 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders     
Depression   0/20 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis   1/20 (5.00%)  1 0/20 (0.00%)  0
Cough   1/20 (5.00%)  1 0/20 (0.00%)  0
Respiratory Congestion   0/20 (0.00%)  0 1/20 (5.00%)  1
Sinus Disorder   0/20 (0.00%)  0 1/20 (5.00%)  1
Sinusitis   4/20 (20.00%)  4 1/20 (5.00%)  1
Upper Respiratory Track Infection   0/20 (0.00%)  0 2/20 (10.00%)  2
Skin and subcutaneous tissue disorders     
1st Degree Burn on Extremity   0/20 (0.00%)  0 1/20 (5.00%)  1
2nd Degree Burn on Extremity   0/20 (0.00%)  0 1/20 (5.00%)  1
Cellulitis   0/20 (0.00%)  0 1/20 (5.00%)  1
Facial Edema   0/20 (0.00%)  0 1/20 (5.00%)  1
Herpes Zoster   0/20 (0.00%)  0 1/20 (5.00%)  1
Oral Lesion   1/20 (5.00%)  1 0/20 (0.00%)  0
Pharyngitis Streptococcal   0/20 (0.00%)  0 1/20 (5.00%)  1
Pharyngolaryngeal Pain   1/20 (5.00%)  1 0/20 (0.00%)  0
Pruritus   0/20 (0.00%)  0 1/20 (5.00%)  1
Rash   1/20 (5.00%)  1 2/20 (10.00%)  2
Surgical and medical procedures     
Dental Implant   1/20 (5.00%)  1 0/20 (0.00%)  0
Ruptured Breast Implant   0/20 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Due to identified lab errors related to processing of samples for CGRP and cytokine levels, samples are currently being re-processed. Results will be posted following re-analysis of all study data related to sample values.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeanne Tarrasch
Organization: Clinvest
Phone: 417-841-3673
EMail: jtarrasch@clinvest.com
Layout table for additonal information
Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT01071096     History of Changes
Other Study ID Numbers: 10-001AL
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: January 16, 2012
Results First Posted: February 17, 2012
Last Update Posted: February 12, 2013