whiplash tension-type headache MedDRA version: 21.1 Level: LLT Classification code 10047930 Term: Whiplash injury to neck System Organ Class: 100000004863 MedDRA version: 21.1 Level: LLT Classification code 10043270 Term: Tension headache (excl migraine) System Organ Class: 100000004852
Conditions
Interventions
Trade Name: pramipexole 1A FARMA
Product Name: pramipexole 1 A Farma
Pharmaceutical Form: Tablet
Other descriptive name: PRAMIPEXOLE HYDROCHLORIDE HYDRATE
Concentration unit: mg milligram(s)
Concentra
Sponsors
University of Copenhagen
jens astrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: whiplash associated disorder grade 2 tension type headache Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age < 50 years no previous whiplash no other chronic pain condition no other chronic diseases pregnancy no safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to relieve neck pain and head ache;Secondary Objective: to improve coordination of head movements;Primary end point(s): relieve of neck pain and headache;Timepoint(s) of evaluation of this end point: prior to treatment 1. week pramipexole 0.18 mg 2. week pramipexole 0.36 mg 3. week pramipexole 0.54 mg A option: To continue treatment for 4 weeks B option: To discontinue treatment and check after 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): improve coordination of head movements;Timepoint(s) of evaluation of this end point: prior to treatment 1. week pramipexole 0.18 mg 2. week pramipexole 0.36 mg 3. week pramipexole 0.54 mg A option: To continue treatment for 4 weeks B option: To discontinue treatment and check after 4 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Neurology
Bispebjerg Hospital
Outcome results
None listed