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Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity

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ClinicalTrials.gov Identifier: NCT00945295
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
JoAnn Harnar, Biomedical Research Institute of New Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Upper Limb Spasticity
Interventions Drug: Botulinum toxin type A, BoNT-A
Other: Rehabilitation Therapy
Enrollment 31
Recruitment Details Thirty one patients with post-stroke upper limb spasticity aged 36 – 75 years were enrolled. Patients were recruited from neurology clinics and through local advertisements.
Pre-assignment Details At the time of consent, all participants agreed that if they were assigned to the BoNT-A no rehab, they would not to start any new therapy or exercise program for arm spasticity until they were finished with the study.
Arm/Group Title Cohort #1 Cohort #2
Hide Arm/Group Description

Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).

Rehabilitation Therapy : Rehabilitation therapy

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Cohort 2 will receive BoNT-A alone

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Period Title: Overall Study
Started 15 16
Completed 15 14
Not Completed 0 2
Arm/Group Title Cohort #1 Cohort #2 Total
Hide Arm/Group Description

Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).

Rehabilitation Therapy : Rehabilitation therapy

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Cohort 2 will receive BoNT-A alone

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  73.3%
9
  56.3%
20
  64.5%
>=65 years
4
  26.7%
7
  43.8%
11
  35.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
58.0  (6.6) 60.9  (11.0) 59.5  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
4
  26.7%
7
  43.8%
11
  35.5%
Male
11
  73.3%
9
  56.3%
20
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15 16 31
1.Primary Outcome
Title The Maximum Change in Fugl-Meyer Upper Extremity Score From the Baseline Exam to Any Post Injection Visit in Each Treatment Arm. Comparison of the Difference Scores Between the Two Groups Will be Considered Significant at p < 0.05.
Hide Description [Not Specified]
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort #1 Cohort #2
Hide Arm/Group Description:

Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).

Rehabilitation Therapy : Rehabilitation therapy

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Cohort 2 will receive BoNT-A alone

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: difference
6.86 3.55
2.Secondary Outcome
Title Length of Time to Meet Re-injection Criteria and the Number of Participants That do Not Meet Re-injection Criteria Prior to Completion of the Study.
Hide Description [Not Specified]
Time Frame 6 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort #1 Cohort #2
Hide Arm/Group Description:

Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).

Rehabilitation Therapy : Rehabilitation therapy

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Cohort 2 will receive BoNT-A alone

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Overall Number of Participants Analyzed 15 16
Measure Type: Number
Unit of Measure: number
4 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort #1 Cohort #2
Hide Arm/Group Description

Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).

Rehabilitation Therapy : Rehabilitation therapy

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

Cohort 2 will receive BoNT-A alone

Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

All-Cause Mortality
Cohort #1 Cohort #2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort #1 Cohort #2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      2/16 (12.50%)    
Nervous system disorders     
hospitalization  [1]  3/15 (20.00%)  3 2/16 (12.50%)  2
Indicates events were collected by systematic assessment
[1]
In cohort 1: 1 with a h/o seizures was hospitalized with seizures. 1 fell and hit head. 1 developed an infection within the pocket containing a defibrillator. In cohort 2: 1 participant was hospitalized with food poisoning. 1 fell and broke wrist.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort #1 Cohort #2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/15 (66.67%)      4/16 (25.00%)    
Blood and lymphatic system disorders     
anemia  [1]  2/15 (13.33%)  2 0/16 (0.00%)  0
General disorders     
pain  [2]  0/15 (0.00%)  0 2/16 (12.50%)  2
Infections and infestations     
infection  [3]  6/15 (40.00%)  6 2/16 (12.50%)  2
Nervous system disorders     
seizures   2/15 (13.33%)  2 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Cohort 1: 2 participants with anemia
[2]
Cohort 2: 1 participant with neck pain; 1 with throat pain
[3]
Cohort 1: 3 UTIs; 1 cold; 1 pneumonia; 1 infected toe Cohort 2: 2 UTIs
This has a single-blind design. Admittedly, a double-blind design is best, but the participants could not be blind to the assignment of rehabilitation. Secondly, the study involved a relatively small sample size and limited follow-up duration.
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: JoAnn Harnar, Research Nurse
Organization: New Mexico VA Healthcare System
Phone: 505-256-5701
Responsible Party: JoAnn Harnar, Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier: NCT00945295     History of Changes
Other Study ID Numbers: Allergan-100808
First Submitted: March 30, 2009
First Posted: July 24, 2009
Results First Submitted: August 20, 2013
Results First Posted: November 1, 2013
Last Update Posted: November 1, 2013