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Cyproheptadine and Chlorpromazine Effects on Spasticity

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: NCT01509885
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date January 10, 2012
First Posted Date January 13, 2012
Last Update Posted Date November 20, 2012
Study Start Date July 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2012)
  • Cutaneomuscular Reflex Responses [ Time Frame: Change after drug intake at baseline, 30minutes, 60minutes, 90minutes and 120minutes ]
    Tibialis anterior reflex responses evoked by stimulation of the medial arch of the foot will be measured before and after drug administration.
  • Paired motor unit recordings [ Time Frame: Change at baseline and 30, 60, 90 and 120min after drug intake ]
    We obtain paired motor unit recordings to determine changes in neuronal excitability after drug intake in incomplete spinal-cord injured subjects only.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01509885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 12, 2012)
Blood pressure and Heart rate [ Time Frame: Change at baseline and 30, 60, 90, 120 minutes after drug intake ]
We measure blood pressure and heart rate to determine the safety of the drug during the experiment and whether we can continue safely.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cyproheptadine and Chlorpromazine Effects on Spasticity
Official Title Phase 3 Study of Cyproheptadine and Chlorpromazine Effects on Spasticity After Spinal Cord Injury
Brief Summary The main goal of this research is to understand the neuronal mechanisms that mediate the development of spasticity and motor dysfunction after spinal cord injury. The investigators examine how neurons and neuronal circuits in an injured nervous system adapt to produce the uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with spinal cord injury. One of the neurons that the investigators study is the motoneuron that excites the muscles of the limbs to produce movement. Previously, the investigators have shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons during muscle spasms is mediated, in large part, by the activation of calcium currents in the human motoneuron. In human patients the investigators have used recordings from single muscle fibres to estimate the contribution of these calcium currents in activating the motoneuron during muscle spasms. In this proposal, the investigators study why motoneurons recover these calcium currents and self-sustained activity after chronic spinal cord injury. Because the calcium currents require the presence of the monoamine serotonin (5HT) to activate, and this monoamine is greatly reduced after injury, the investigators examine if the calcium currents recover because the 5HT receptors become spontaneously active without the need for 5HT to bind to the receptor, which the investigators hypothesize to be one of the causes of spasticity after spinal cord injury. This research will pave the way to develop new pharmacological and rehabilitative therapies to both control spasticity after spinal cord injury and augment residual motor movements.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Spinal Cord Injury Patients
Condition
  • Spinal Cord Injuries
  • Muscle Spasticity
Intervention Not Provided
Study Groups/Cohorts
  • Complete Spinal Cord Injured Subjects
    Patients with no motor scores in their legs and suffering a complete spinal cord injury.
  • Incomplete Spinal Cord Injured Subjects
    Patient with some motor preservation below the injury and suffering an incomplete spinal cord injury.
Publications * Murray KC, Nakae A, Stephens MJ, Rank M, D'Amico J, Harvey PJ, Li X, Harris RL, Ballou EW, Anelli R, Heckman CJ, Mashimo T, Vavrek R, Sanelli L, Gorassini MA, Bennett DJ, Fouad K. Recovery of motoneuron and locomotor function after spinal cord injury depends on constitutive activity in 5-HT2C receptors. Nat Med. 2010 Jun;16(6):694-700. doi: 10.1038/nm.2160. Epub 2010 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2012)
20
Original Actual Enrollment Same as current
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients must have suffered a trauma to the spinal cord at least 6 months ago or longer. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score, as assessed by a physical therapist, greater than 1.

Exclusion Criteria:

  • If patients have damage to the nervous system other than to the spinal cord
  • Pregnant women
  • Elderly Patients and debilitated patients
  • Alcoholic Patients
  • Patients with:

    • Known or suspected allergy to the medication or its ingredients
    • Cardiovascular disease
    • Hypotension
    • Coronary artery disease
    • Reduced liver or kidney function
    • Comatose or depressed states due to CNS depressants
    • Blood dyscrasias
    • Bone marrow depression
    • History of seizures
    • Respiratory problems
    • Hypocalcemia
    • Monoamine oxidase inhibitor therapy
    • Angle-closure glaucoma
    • Stenosing peptic ulcer
    • Symptomatic prostatic hypertrophy
    • Bladder neck obstruction
    • Pyloroduodenal obstruction
    • History of bronchial asthma
    • Increased intraocular pressure
    • Hyperthyroidism
    • Cardiovascular disease
    • Hypertension
  • Patients taking:

    • Amphetamines
    • Antihistamines-second generation
    • Anticonvulsants
    • Anticholinergics
    • CNS depressants
    • Antidepressants
    • Hypotensive agents
    • Levodopa
    • Lithium
Sex/Gender
Sexes Eligible for Study: All
Ages 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01509885
Other Study ID Numbers Pro00020682
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Alberta
Study Sponsor University of Alberta
Collaborators Not Provided
Investigators
Principal Investigator: Monica A Gorassini, PhD University of Alberta
PRS Account University of Alberta
Verification Date November 2012