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Trial record 58 of 165 for:    trisomy21 NOT prenatal

Rivastigmine Study in Adolescents With Down Syndrome (DS-Riv)

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: NCT01084135
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : March 12, 2015
Last Update Posted : April 6, 2015
Sponsor:
Collaborators:
Taishoff Family Foundation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Down Syndrome
Interventions Drug: Rivastigmine
Other: Liquid Placebo
Enrollment 42
Recruitment Details 8 participant started and completed the 12 week period. The protocol was amended and 23 subject enrolled into the 20 week amended period (22 completed).
Pre-assignment Details 42 subjects signed consent, 10 were screen failures, 1 withdrew consent prior to being assigned to an arm, 1 was withdrawn by PI after being assigned an arm for noncompliance, 30 completed study.
Arm/Group Title Rivastigmine- Liquid Form Liquid Placebo
Hide Arm/Group Description At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Period Title: 12 Week
Started 4 4
Completed 4 4
Not Completed 0 0
Period Title: 20 Week
Started 12 11
Completed 12 10
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
Arm/Group Title 20 Week Rivastigmine- Liquid Form 20 Week Liquid Placebo 12 Week Rivastigmine- Liquid Form 12 Week Liquid Placebo Total
Hide Arm/Group Description At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Total of all reporting groups
Overall Number of Baseline Participants 12 11 4 4 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 4 participants 4 participants 31 participants
<=18 years
12
 100.0%
11
 100.0%
4
 100.0%
4
 100.0%
31
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 4 participants 4 participants 31 participants
Female
8
  66.7%
6
  54.5%
2
  50.0%
2
  50.0%
18
  58.1%
Male
4
  33.3%
5
  45.5%
2
  50.0%
2
  50.0%
13
  41.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 11 participants 4 participants 4 participants 31 participants
12 11 4 4 31
1.Primary Outcome
Title Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)
Hide Description The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject’s ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.
Time Frame Baseline & Study termination (Week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 20 week period were included in analysis except for 2 subjects whose form was completed incorrectly.
Arm/Group Title Rivastigmine- Liquid Form Liquid Placebo
Hide Arm/Group Description:
At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.7  (3.2) 2.0  (3.6)
2.Secondary Outcome
Title Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)
Hide Description The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting. It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales. Raw scores range from 63 to 189. Higher scores suggest that an individual’s executive function skills are more problematic. In this study, the change between each subject’s raw score at Baseline and the Final Visit was computed for the Global Executive Composite. A decline in raw scores from Baseline to the Final Visit indicates improvement.
Time Frame Baseline and Final (Week 20) visit
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 20 week period were included in analysis except for 1 subjects whose form was completed incorrectly.
Arm/Group Title Rivastigmine- Liquid Form Liquid Placebo
Hide Arm/Group Description:
At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.

Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.

Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.6  (7.7) -6.1  (12.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 20 Week: Rivastigmine- Liquid Form 20 Week: Liquid Placebo 12 Week: Rivastigmine- Liquid Form 12 Week: Liquid Placebo
Hide Arm/Group Description At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study. Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste. At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks. Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
All-Cause Mortality
20 Week: Rivastigmine- Liquid Form 20 Week: Liquid Placebo 12 Week: Rivastigmine- Liquid Form 12 Week: Liquid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
20 Week: Rivastigmine- Liquid Form 20 Week: Liquid Placebo 12 Week: Rivastigmine- Liquid Form 12 Week: Liquid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
20 Week: Rivastigmine- Liquid Form 20 Week: Liquid Placebo 12 Week: Rivastigmine- Liquid Form 12 Week: Liquid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   8/11 (72.73%)   3/4 (75.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders         
Lumps in neck  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Eye disorders         
Eye twitch  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Diarrhea  3/12 (25.00%)  2/11 (18.18%)  0/4 (0.00%)  3/4 (75.00%) 
Nausea  3/12 (25.00%)  3/11 (27.27%)  1/4 (25.00%)  1/4 (25.00%) 
Stomach ache  5/12 (41.67%)  3/11 (27.27%)  0/4 (0.00%)  1/4 (25.00%) 
Vomiting  3/12 (25.00%)  1/11 (9.09%)  1/4 (25.00%)  2/4 (50.00%) 
Indigestion  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Constipation  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sleepy  2/12 (16.67%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
excessive gas  0/12 (0.00%)  0/11 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
General disorders         
Cold  3/12 (25.00%)  2/11 (18.18%)  0/4 (0.00%)  0/4 (0.00%) 
Stomach flu  2/12 (16.67%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Fever  0/12 (0.00%)  2/11 (18.18%)  0/4 (0.00%)  0/4 (0.00%) 
Fatigue  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders         
Increased bilirubin  0/12 (0.00%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Vaginal yeast infection  0/12 (0.00%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Cut  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1/12 (8.33%)  1/11 (9.09%)  1/4 (25.00%)  1/4 (25.00%) 
Weight gain  0/12 (0.00%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Weakness  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Leg cramps  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nervous system disorders         
Dizziness  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  2/4 (50.00%) 
Headache  1/12 (8.33%)  1/11 (9.09%)  1/4 (25.00%)  0/4 (0.00%) 
Trouble sleeping  1/12 (8.33%)  1/11 (9.09%)  0/4 (0.00%)  2/4 (50.00%) 
Shakiness  0/12 (0.00%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
Restless legs  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Foot twitching  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Fainted  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Psychiatric disorders         
Assertive, stubborn, more emotional  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
behavior problems  0/12 (0.00%)  0/11 (0.00%)  3/4 (75.00%)  1/4 (25.00%) 
nightmares  0/12 (0.00%)  0/11 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Renal and urinary disorders         
Incontinence  1/12 (8.33%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
Frequent urination  0/12 (0.00%)  1/11 (9.09%)  1/4 (25.00%)  0/4 (0.00%) 
Urinary track infection  0/12 (0.00%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders         
Menstural cramps  2/12 (16.67%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Nasal congestion  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Boil  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pale coloring  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Itchy  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rash  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Worsening acne  1/12 (8.33%)  0/11 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Worsening alopecia  0/12 (0.00%)  1/11 (9.09%)  0/4 (0.00%)  0/4 (0.00%) 
acne  0/12 (0.00%)  0/11 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
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
Name/Title: Jane Ann Baker,MS, CGC
Organization: Duke University Medical Center
Phone: 919-668-4576
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01084135     History of Changes
Other Study ID Numbers: Pro00013682
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: February 27, 2015
Results First Posted: March 12, 2015
Last Update Posted: April 6, 2015