EUCTR2010-019198-14-SE
Active, not recruiting
Not Applicable
Icke-motoriska och hälsoekonomiska effekter av intermittent subkutan apomorfinbehandling vid Parkinsons sjukdom
Karolinska Universitetssjukhuset Huddinge0 sites30 target enrollmentSeptember 17, 2010
ConditionsParkinsons sjukdom
DrugsApo-GO Pen
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinsons sjukdom
- Sponsor
- Karolinska Universitetssjukhuset Huddinge
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosen Parkinsons sjukdom
- •kvarstående motoriska svängningar (wearing\-off,”on\-off”\-perioder) trots individuellt utprovad behandling med L\-dopa (med en perifer dekarboxylashämmare) med eller utan tilläggsbehandling (dopaminagonister, COMT alternativt MAO\-B)
- •förekomst av fatigue, ångest och/eller depression enligt WOQ\-19 (positivt svar på fråga 17 och/eller 18\), NMSQuest (positivt svar på fråga 16 och/eller 17\), FACIT\-F (\=34 poäng) och/eller HADS (\>7 poäng)
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •pågående kliniskt signifikanta psykiatriska komplikationer
- •andningsdepression
- •psykotiska sjukdomar
- •leverinsufficiens
- •känd överkänslighet mot apomorfin eller någon annan ingående substans
- •svåra L\-dopa inducerade dyskinesier
Outcomes
Primary Outcomes
Not specified
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