Not provided
Not provided
Not provided
Not provided
Based on efficacy results from interim analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Danderyd Hospital | OTHER |
| Karolinska University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin-A (Dysport®) | Active Comparator | Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain |
|
| Normal saline | Placebo Comparator | Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dysport® | Drug | Intramuscular injections in spastic muscle with regional muscle-related pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Proportion of responders derived as reduction of intensity of pain of ≥2 points on the Numerical Rating Scale (NRS) at Visit 3 (six weeks after treatment) compared to baseline. | Six weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Use of other analgesic treatment | Categories of change in the use of analgesic treatments, derived as Increase, No change, or Decrease at Visit 3 (six weeks after treatment), compared to baseline. | Six weeks after treatment |
| Pain interference |
| Measure | Description | Time Frame |
|---|---|---|
| HRQoL (Health-Related Quality of Life) | Mean change at Visit 3 (six weeks after treatment) compared to baseline in the Short Form 36 v2 Health-related Quality of Life questionnaire (SF-36v2) | Six weeks after treatment |
| Global Impression of Change |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristina Tedroff, MD, PhD | Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine at Danderyd Hospital AB | Danderyd | 182 88 | Sweden | |||
| Astrid Lindgren's Children's Hospital at Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34484101 | Derived | Jacobson D, Lowing K, Kullander K, Rydh BM, Tedroff K. A First Clinical Trial on Botulinum Toxin-A for Chronic Muscle-Related Pain in Cerebral Palsy. Front Neurol. 2021 Aug 16;12:696218. doi: 10.3389/fneur.2021.696218. eCollection 2021. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D002547 | Cerebral Palsy |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
Not provided
Not provided
| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Drug | Intramuscular injections in spastic muscle with regional muscle-related pain |
|
|
Proportion of responders derived as a reduction in mean interference score of ≥1 on the Brief Pain Inventory (BPI-SF) at Visit 3 (six weeks after treatment) compared to baseline.
| Six weeks after treatment |
Proportion of responders at Visit 3 (six weeks after treatment) in the Global Impression of Change Scale (PGIC) derived as at least "Minimally improved".
| Six weeks after treatment |
| Fatigue Severity Scale | Proportion of responders at Visit 3 (six weeks after treatment) in the Fatigue Severity Scale (FSS) derived as a reduction in mean score of ≥1 point. | Six weeks after treatment |
| Spasticity | Proportion of responders at Visit 3 (six weeks after treatment) derived as achieving reduction of spasticity of >1 scale steps on the Modified Ashworth Scale (MAS) | Six weeks after treatment |
| Range of Motion | Proportion of responders at Visit 3 (six weeks after treatment) derived as improvement in passive joint range of motion (ROM) ≥ 10 degrees. | Six weeks after treatment |
| Adverse Events | Frequency of adverse events | Six weeks after treatment |
| Stockholm |
| 171 76 |
| Sweden |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |